Platelet-activation and optimal inhibition in patients with Atrial Fibrillation undergoing LAA closure; The POPULAR-LAAO trial

Recruiting

• Conditions: Afib; Atrial fibrillation; 10007521

• Registration Number: NL-OMON49947
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

- The subject is aged 18 years or older
- The subject is accepted/scheduled for left atrial appendage closure
- The subject has a CHA*DS*-VASc Score >=2 (male) or >=3 (female)
- The subject or legal representative is able to understand and is willing to
provide written informed consent to participate in the trial.

Exclusion Criteria

- Unable or unwilling to return for required follow-up visits and examinations
- Mechanical heart valves or valvular disease requiring surgery or
interventional procedure
- Ongoing major bleeding or complicated or recent (<72hours) major surgery
- Known large oesophageal varices or decompensated liver disease (unless a
documented positive opinion of a gastro-enterologist)
- Severe thrombocytopenia (<50,000/ml)
- High likelihood of being unavailable for follow-up or psycho-social condition
making study participation impractical.
- Woman with child bearing potential who do not use an efficient method of
contraception.
- Positive serum or urine pregnancy test for woman with child bearing potential
- Pregnancy or within 48 hours post-partum
- unsuitable LAA anatomy for closure or thrombus in the LAA at the time of
procedure
- contraindications or unfavourable conditions to perform cardiac
catheterization or TEE
- atrial septal malformations, atrial septal defect or a high-risk patient
foramen ovale that may cause thrombo-embolic events
- atrial septal defect repair or closure device or a patent foramen ovale
repair or any other anatomical condition as this may preclude an LAAO procedure
- Mitral valve regurgitation grade 3 or more
- Aortic valve stenosis (AVA<1.0 cm2 or Pmax>50 mmHg) or regurgitation grade 3
or more
- Planned CEA for significant carotid artery disease
- Life expectancy of less than 1 year

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified